Mometasone Furoate (Asmanex Hfa)

Trade Name : ASMANEX HFA

Merck Sharp & Dohme Corp.

AEROSOL

Strength 50 ug/1

MOMETASONE FUROATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Mometasone Furoate (Asmanex Hfa) which is also known as ASMANEX HFA and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 50 ug/1 per ml. Read more

Mometasone Furoate (Asmanex Hfa) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

No data

ASMANEXHFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older.
Important Limitations of Use
ASMANEX HFA is a corticosteroid indicated for:
Important limitations:

For oral inhalation only. ()

Treatment of asthma in patients 12 years of age and older: 2 inhalations twice daily of ASMANEX HFA 100 mcg or 200 mcg. Starting dosage is based on prior asthma therapy. ()
Treatment of asthma in patients aged 5 to less than 12 years: 2 inhalations twice daily of ASMANEX HFA 50 mcg. ()

ASMANEX HFA is a pressurized metered dose inhaler (MDI) that is available in 2 strengths (100 mcg and 200 mcg) for adult and adolescent patients aged 12 years and older; and 1 strength (50 mcg) for pediatric patients aged 5 to less than 12 years.
ASMANEX HFA 50 mcg delivers 50 mcg of mometasone furoate per actuation.
ASMANEX HFA 100 mcg delivers 100 mcg of mometasone furoate per actuation.
ASMANEX HFA 200 mcg delivers 200 mcg of mometasone furoate per actuation.
Each strength of ASMANEX HFA is supplied with a blue colored actuator and pink dust cap .

Inhalation aerosol containing 50 mcg, 100 mcg, or 200 mcg of mometasone furoate per actuation. ()

No data

Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ()
Hypersensitivity to any of the ingredients of ASMANEX HFA. ()

No data

Deterioration of asthma and acute episodes: ASMANEX HFA should not be used for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ()
Localized infections: infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. After dosing, advise patients to rinse their mouth with water and spit out contents without swallowing. ()
Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Use with caution in patients with these infections because of the potential for worsening of these infections. ()
Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Wean patients slowly from systemic corticosteroids if transferring to ASMANEX HFA. ()
Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ASMANEX HFA slowly. ()
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects. Exercise caution when used with ASMANEX HFA. ()
Paradoxical bronchospasm: Discontinue ASMANEX HFA and institute alternative therapy if paradoxical bronchospasm occurs. ()
Hypersensitivity reactions including anaphylaxis: Hypersensitivity reactions, such as urticaria, flushing, allergic dermatitis, bronchospasm, rash, pruritus, angioedema, and anaphylactic reaction may occur. Discontinue ASMANEX HFA if such reactions occur. ()
Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. ()
Effects on growth: Monitor growth of pediatric patients. ()
Glaucoma and cataracts: Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX HFA long term. ()

Systemic and local corticosteroid use may result in the following:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Most common adverse reactions (reported in greater than or equal to 3% of patients) included:
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

nasopharyngitis, headache, sinusitis, bronchitis, and influenza. ()

In clinical trials, concurrent administration of ASMANEX HFA and other drugs, such as short-acting beta-agonist and intranasal corticosteroids have not resulted in an increased frequency of adverse drug reactions. No formal drug interaction studies have been performed with ASMANEX HFA.
The main route of metabolism of corticosteroids, including mometasone furoate, is via CYP3A4. After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally inhaled mometasone furoate increased. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects. Caution should be exercised when considering the coadministration of ASMANEX HFA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) . Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.

Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. ()

No data

Hepatic impairment: Monitor patients for signs of increased drug exposure. ()

Chronic overdosage may result in signs/symptoms of hypercorticism . Single oral doses up to 8000 mcg of mometasone furoate have been studied on adult subjects with no adverse reactions reported.

ASMANEX HFA is a metered dose inhaler for oral inhalation only, consisting of 50 mcg, 100 mcg, or 200 mcg of mometasone furoate per actuation.
Mometasone furoate, the active component of ASMANEX HFA, is a corticosteroid having the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16 (alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) with the following chemical structure:
Mometasone furoate is a white powder with an empirical formula of CHClO, and molecular weight 521.44. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone.
ASMANEX HFA 50 mcg, 100 mcg, and 200 mcg are each formulated as a hydrofluoroalkane (HFA-227: 1,1,1,2,3,3,3-heptafluoropropane) propelled pressurized metered dose inhaler containing sufficient amount of drug for 120 actuations . After priming, each actuation of the inhaler delivers 60, 115, or 225 mcg of mometasone furoate in 69.6 mg of suspension from the valve and delivers 50, 100, or 200 mcg of mometasone furoate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. ASMANEX HFA also contains ethanol as a cosolvent and oleic acid as a surfactant.
ASMANEX HFA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.

No data

In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcg/kg (approximately 14 times the MRHD on an AUC basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 9 times the MRHD on an AUC basis).
Mometasone furoate increased chromosomal aberrations in an Chinese hamster ovary cell assay, but did not have this effect in an Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in rat hepatocytes.
In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/kg (approximately 8 times the MRHD on an AUC basis).

No data

No data

Advise the patient to read the FDA-approved patient labeling ( and ).

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
Manufactured by: 3M Health Care Ltd., Loughborough, United Kingdom.
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2014-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-mk0887-ao-1908r005

No data

ASMANEX HFA (AZ-ma-neks) 50 mcg ASMANEX HFA 100 mcg ASMANEX HFA 200 mcg (mometasone furoate)Inhalation Aerosol
Read these Instructions for Use before you start using ASMANEX HFA and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment.
The parts of your ASMANEX HFA:
There are 2 main parts to your ASMANEX HFA inhaler: the metal canister that holds the medicine and the blue plastic actuator that sprays the medicine from the canister.
Important Information:
Before using your ASMANEX HFA:
Remove the cap from the mouthpiece of the actuator before using ASMANEX HFA (see )
Priming your ASMANEX HFA Inhaler:
Before you use ASMANEX HFA for the first time, you must prime the inhaler.
Using your ASMANEX HFA:
After using your ASMANEX HFA inhaler:
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Reading the counter:
When to replace your ASMANEX HFA:
How to clean your ASMANEX HFA:
The mouthpiece should be cleaned using a dry wipe after every 7 days of use.
Routine cleaning instructions:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
Manufactured by: 3M Health Care Ltd., Loughborough, United Kingdom.
For patent information: www.merck.com/product/patent/home.html
The trademarks depicted herein are owned by their respective companies.
Copyright u00a9 2014-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
Revised: 08/2019 usppi-mk0887-ao-1908r003

NDC 0085-4333-01
Asmanexn- HFA(mometasone furoate)n n
100 mcgn
For oral inhalation only
Asmanex HFA canister to be usedwith Asmanex HFA actuator only.
SHAKE WELL BEFORE USING.
Rx only
120 Metered ActuationsNet Wt. 13g

NDC 0085-4334-01
Asmanexn- HFA(mometasone furoate)n n
200 mcgn
For oral inhalation only
Asmanex HFA canister to be usedwith Asmanex HFA actuator only.
SHAKE WELL BEFORE USING.
Rx only
120 Metered ActuationsNet Wt. 13g

NDC 0085-2222-01
Asmanex HFA(mometasone furoate)Inhalation Aerosol
50 mcg per actuation
For oral inhalation only
Asmanex HFA canister to be usedwith Asmanex HFA actuator only.
SHAKE WELL BEFORE USING.
Rx only
120 Metered ActuationsNet Wt. 13g

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Mometasone Furoate (Asmanex Hfa)

Trade Name : ASMANEX HFA

AEROSOL

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Mometasone Furoate (Asmanex Hfa)

Trade Name : ASMANEX HFA

AEROSOL

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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